Kornimate/medical-research-clean huggingface dataset:
dose finding study of gadavist in central nervous system (cns) magnetic resonance imaging (mri)

Conditions: Brain Diseases; Spinal Cord Diseases

Summary: the purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadavist when used for taking images of the brain and spine. the results of the mri with gadavist injection will be compared to the results of mr images taken without contrast and with the results of the mr images taken with optimark.

safety issues are addressed in the adverse events section

Eligibility criteria:
inclusion criteria: * patients with either known or highly suspected focal areas of disruption of the blood brain barrier (bbb) (eg, primary and secondary tumors, focal inflammatory or demyelinating disorders) and/or abnormal vascularity in the cns, who are scheduled to undergo a routine contrast-enhanced mri of the cns. * patients with untreated brain tumors should constitute a minimum of 50% of the study population and patients with treated brain tumors will be limited to a maximum of 20% of the study population exclusion criteria: * is a female patient who is pregnant or nursing. * is a female of childbearing potential and did not have a negative urine pregnancy test the same day as the administration of gadobutrol or comparator treatment. * has received any investigational product within 30 days prior to enrolling in this study. * has been previously enrolled in this study or any other study using gadobutrol. * has any contraindication to the mri examinations. * has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents. * has received any contrast agent within 24 hours prior to gadobutrol contrast administration, or is scheduled to receive any contrast agent within 72 hours after the gadobutrol study. * is considered to be clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure). * has been treated with high dose (\>55 cobalt gy equivalent) photon radiation or global radiotherapy for cns lesions at any time before entering the study. * is scheduled to receive chemotherapy or radiotherapy during the study period. * is expected or scheduled to have a change in any treatment or procedure between the comparator and gadobutrol mris that may alter their interpretation. * is scheduled or is likely to require a biopsy or surgery within the 72 hours after the gadobutrol mri procedure, or is scheduled for or has undergone such interventions between the comparator and gadobutrol studies. * has severe cardiovascular disease. * has any contraindication to optimark according to the package insert. * has more than 30 brain lesions detected by any prior imaging examination.

Keywords: contrast agents
the ct-verified data collection study to investigate the correlation between the leadless pacemaker tip location and echo, ecg

Conditions: Bradycardia Sinus; AV Block; Atrial Fibrillation (AF)

Summary: the goal of this observational study is to assess inter-/intra- ventricular synchrony and ecg characteristics in relation to micra tip location. the secondary objective is (1) to identify an optimal micra pacing location to improve lv function, (2) to investigate the correlation between micra tip location and tricuspid regurgitation, and (3) to investigate whether micra location would impact av synchrony. patients with pacing indications who plan to receive micra av implantation will be recruited.


Eligibility criteria:
inclusion criteria: * patients aged above 18 years old * patients who are willing to provide informed consent * patients with class i or ii indications who plan to receive a leadless pacemaker, including sss, avb, af with bradycardia, etc. * patients who plan to conduct a cardiac ct scan after implantation exclusion criteria: * patients with lead retention * patients had heart valve replacement * patients diagnosed with ischemic heart diseases * patients who are allergic to or refuse to use contrast in ct scans * patients who are pregnant or have a plan for pregnancy during the study * patients with medical conditions that would limit study participation * patients already enrolled in another clinical trial which would impact participation of this study
dexmedetomidine for postoperative analgesia after bariatric surgery

Conditions: Obesity; Sleep Apnea; Diabetes; Hypertension

Summary: the purpose of this study is to determine if dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.

effect of dexmedetomidine bolus on postoperative morphine requirements

Eligibility criteria:
inclusion criteria: * body mass index \> 40 kg/m2 or bmi \> 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea * american society of anesthesiologists class i or ii * undergoing laparoscopic sleeve gastrectomy bariatric surgery exclusion criteria: * allergy to morphine or its derivatives * allergy to α-2 adrenergic agonists * weight over 180 kg * history of uncontrolled hypertension * heart block greater than first degree * prolonged qt interval * clinically significant neurologic, cardiovascular, renal, hepatic, or gastrointestinal diseases * received an opioid analgesic medication within a 24 h period prior to surgery * history of alcohol, drug abuse or chronic opioid intake * history of psychiatric disorder * pregnant or breastfeeding.

Keywords: dexmedetomidine bariatric surgery postoperative pain morphine consumption quality of recovery
brief cognitive behavioral therapy replication trial

Conditions: Suicide, Attempted; Suicidal Ideation

Summary: the overall goal for the proposed project is to test the effectiveness of bcbt for the prevention of suicide attempts in a sample of treatment-seeking u.s. military personnel and veterans. the standard null hypothesis will involve tests conducted comparing improvement following bcbt (treatment duration of 12 weeks) to person-centered therapy (pct). the primary outcome comparisons will include direct markers of suicidality (i.e. suicide, suicide attempts). secondary outcomes will be suicide ideation and indicators of psychiatric distress (e.g., depression, hopelessness). we also aim to assess several hypothesized psychological and neurocognitive mediators of treatment effects (e.g., wish to live, attentional bias, emotion regulation). participants will be followed for 2 years posttreatment by independent evaluators blind to treatment condition.

the number of suicides by military personnel and veterans has steadily increased during the past few decades and remains elevated. previous research conducted with active duty army personnel supports the superiority of bcbt and its components over treatment as usual for the reduction of suicide attempts. additional research is needed to determine if these effects are generalizable to military personnel and veterans more broadly and to confirm hypothesized mechanisms of action. reference to "active duty" refers to u.s. military service members that have been activated and deployed as a part of operation iraqi freedom/operation enduring freedom (oif/oef) in accordance with federal orders under title 10 or 32, united states code. reference to "veteran" refers to any person who has served in the u.s. military at any time, regardless of branch, component, era, or discharge status. specific aim 1:to replicate previous findings supporting the efficacy of bcbt for the prevention of suicide attempts among military personnel and veterans (regardless of axis i or ii diagnosis). the standard null hypothesis will involve tests conducted comparing improvement following bcbt to present-centered therapy (pct) specific aim 2: to identify cognitive-affective mediators of bcbt's effects on risk for suicide attempt.

Eligibility criteria:
inclusion criteria: * current or past service in the u.s. military * 18 years of age or older * reporting current suicide ideation with intent to die and/or a suicide attempt within the past two weeks * ability to understand and speak the english language; and ability to complete the informed consent process. exclusion criteria: * psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication).

Keywords: suicide suicidal ideation ambivalence suicide ambivalence reasons for living reasons for dying military clinical trial cognitive behavioral therapy psychotherapy crisis crisis response plan (crp) present centered therapy (pct) brief cognitive-behavioral therapy (bcbt)
detection of breast cancer with non-invasive method based on dna methylation of circulated tumor dna, pbmc

Conditions: Breast Cancer; Breast Cancer Female

Summary: a central challenge in the fight against breast cancer is how to detect disease in a noninvasive manner before it is detectable by imaging methods. although inroads have been made with more sensitive imaging techniques for earlier detection of breast cancer, these techniques are limited by the size of lesion that could be detected. alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. consequently, effective non-invasive tools as prognostic indicators and biomarkers of breast cancer are urgently needed. the purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in pbmc and circulated tumor dna in breast cancer patients.


Eligibility criteria:
inclusion criteria: * histological confirmed breast cancer subtypes (dcis and invasive) exclusion criteria: * pregnant women * minors (subjects less than 18 years of age) * prisoners * patients with known infectious disease, such as human immunodeficiency virus (hiv), tuberculosis (tb), or hepatitis b, c * patients having other than one cancer * subjects unable to consent for themselves
vitamin d raising and maintaining blood serum 25(oh)d3 levels

Conditions: Vitamin D Deficiency

Summary: analyze the amount of change in blood serum vitamin d levels in patients of 3 different dosing groups and how their levels change over a 3 month period of time.

vitamin d has shown multiple health benefits specifically in regards to bone healing. to the investigators knowledge there are currently no protocols for vitamin d supplementation in the orthopedic community for patients recovering from fractures. the investigators study will monitor 3 different groups of volunteers taking various vitamin d regimens and how participants blood serum 25(oh)d3 levels are effected throughout a 3 month period. the 3 groups will include: 1) 100,000 units d2 once on day one, 2) 100,000 units d2 taken once a week x 12 weeks, 3) 50,000 units d2 x 10 days, then 2000 units d3 taken daily for the remainder of the study period. there will be 15-20 volunteers randomly assigned to each of the 3 groups. the investigators will have each volunteer from the 3 groups have blood drawn a total of 4 times throughout the course of this study: prior to the study, week 2, week 6, and week 12. from these results the investigators will determine which protocol most effectively raises and maintains vitamin d levels in the volunteers through this 3 month period. the investigators will also use this data to determine which protocol is not only most cost efficient but also easiest to follow by individuals. the investigators are hoping that this study may help finally develop a universal orthopedic protocol for vitamin d supplementation in patients recovering from fractures.

Eligibility criteria:
inclusion criteria: * low vitamin d level exclusion criteria: * normal vitamin d level, already taking vitamin d, any form of steroids, weight-loss drugs, anti-tuberculosis drugs, high blood pressure drugs, high cholesterol drugs, endocrine disease, being treated for any form of cancer.

Keywords: vitamin d dosing regimens blood serum 25(oh)d3 levels
99mtc-darping3-based her2 expression molecular imaging in her2-positive breast cancer during chemo+targeted therapy

Conditions: HER2-positive Breast Cancer; Female

Summary: an open-label, single center study with 99mtc-darping3 spect and biopsies of primary tumour in her2-positive breast cancer in dynamic of chemo+targeted therapy, where the primary endpoint of the study is to find out the correlation between the her2 expression measured by 99mtc-darpin g3 spect and standard histopathology from primary tumor in dynamic of chemo+targeted therapy.

none methodology: open-label, exploratory, single center study. the subjects will receive a single injection of the labelled tracer.

Eligibility criteria:
inclusion criteria: 1. subject is \> 18 years of age; 2. diagnosis of primary breast cancer with tumour size ≥ 20 mm and with possible lymph node metastases; 3. availability of results from her2 status previously determined on material from the primary tumor: her2-positive, defined as a dako herceptest™ score of 3+ or fish positive; 4. in neoadjuvant all patients should receive standard chemo-targeted therapy according to the dch+p (docetaxel + carboplatin+ trastuzumab+ pertuzumab) scheme; 5. injection of 99mtc-darping3 at the dosage 3000 µg before and after 2 and 4 courses of chemo+targeted therapy in each her2-positive breast cancer patient; 6. biopsies should be performed in all patients her2-positive breast cancer patients before and after 2 and 4 courses of chemo+targeted therapy with evaluation of her2 expression; 7. hematological, liver and renal function test results within the following limits: * white blood cell count: \> 2.0 x 109/l * hemoglobin: \> 80 g/l * platelets: \> 50.0 x 109/l * alt, alp, ast: =\< 5.0 times upper limit of normal * bilirubin =\< 2.0 times upper limit of normal * serum creatinine: within normal limits 8. a negative pregnancy test for all patients of childbearing potential. sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination; 9. subject is capable to undergo the diagnostic investigations to be performed in the study; 10. informed consent exclusion criteria: 1. second, non-breast malignancy 2. active current autoimmune disease or history of autoimmune disease 3. active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) 4. known hiv positive or chronically active hepatitis b or c 4. administration of other investigational medicinal product within 30 days of screening 5. ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to us national cancer institute's

Keywords: 99mtc-darping3 breast cancer her2 expression chemotherapy and targeted therapy
topotecan plus cisplatin versus etoposide plus cisplatin in 1st line extensive disease small cell lung cancer

Conditions: Lung Cancer, Small Cell

Summary: evaluation of intravenous topotecan + cisplatin as a potential new standard of care in 1st line small cell lung cancer


Eligibility criteria:
inclusion criteria: * evaluable extensive small cell lung cancer, extensive disease. * eastern cooperative oncology group (ecog) performance status \< 2. * life expectancy \> 3 months. * fit to receive any of the treatments. * no prior chemotherapy. * written informed consent. exclusion criteria: * extensive disease treatable with radiotherapy. * past or current history of other malignant disease. * prior chemotherapy. * pregnancy, lactating or lack of effective contraception. * concurrent severe medical problems other than small cell lung cancer. * patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.

Keywords: first-line cisplatin small cell lung cancer topotecan etoposide extensive disease
stereotactic radiation therapy in treating patients with brain metastases

Conditions: Metastatic Cancer

Summary: rationale: stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. purpose: phase ii trial to study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.

objectives: i. determine the efficacy of stereotactic radiosurgery without whole brain radiotherapy in elderly patients or patients with poor performance status who have brain metastases. ii. determine the neurologic function in these patients after receiving this treatment regimen. iii. determine the quality of life in these patients with this treatment regimen. outline: patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using gamma knife, on day 1. quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years. projected accrual: approximately 52 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: patients with 1-4 sites of brain metastases confirmed by mri with gadolinium texaphyrin scan within two weeks of study if solitary metastases, diameter must be 40 mm or less if multiple metastases, one site may be greater than 30 mm, while all others must be less than 30 mm no metastases in the brainstem or within 5 mm of optic nerves or chiasm prior surgical resection of metastases allowed if radiographically visible residual disease no prior cranial radiotherapy patients must be over 65 years of age or over 18 years of age with karnofsky performance status 40-60% all primary histologies allowed except the following: lymphomas leukemia multiple myeloma small cell lung cancer germ cell tumors extracranial disease allowed patient characteristics: age: see disease characteristics performance status: see disease characteristics life expectancy: not specified hematopoietic: hemoglobin greater than 8 g/dl absolute neutrophil count greater than 1,000/mm3 platelet count greater than 50,000/mm3 hepatic: not specified renal: not specified prior concurrent therapy: biologic therapy: not specified chemotherapy: prior chemotherapy allowed endocrine therapy: not specified radiotherapy: see disease characteristics prior or concurrent radiotherapy to noncranial sites allowed surgery: see disease characteristics

Keywords: tumors metastatic to brain
a study comparing outcomes of kidney transplants in patients on steroids versus those who discontinue steroids

Conditions: Kidney Diseases

Summary: the purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass, lipids, hypertension, and new onset diabetes.

the use of steroids after renal transplantation has been invaluable, resulting in higher rates of long term survival of the transplanted kidney. however, post-operative steroids are also associated with frequent post-operative and long term complications. there have been steroid elimination studies analyzing acute rejection rates, graft and patient survival. these studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids. with this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids. we hope to show a decreased rate of complications such as osteopenia/osteoporosis, new onset diabetes, and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension. solumedrol will be given to all patients at the time of transplant followed by a prednisone taper. those remaining on steroids will be discharged on prednisone 5 mg daily. those in whom steroids are eliminated will be off prednisone by discharge.

Eligibility criteria:
inclusion criteria: * patients undergoing a single renal transplant from deceased or living donor * adults 18 years and older * first or second renal transplant * capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements * women of child bearing age should have a negative serum pregnancy test exclusion criteria: * greater than 2 renal transplants * age \< 18 years * patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant * cold ischemia time \> 30 hours * history of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer * hiv, hepatitis b virus (hbv), or hepatitis c virus (hcv) positive serology * loss of previous transplant in \< 1 year * history of non-compliance * any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures * multiple organ transplant * history of chronic steroid use except for inhaled steroids for asthma * pregnant or lactating females * women of childbearing potential not willing to use a reliable form of contraception. * patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study * known sensitivity to study drugs or class of study drugs * use of any investigational agent in the last 30 days

Keywords: renal transplantation
a study to investigate the effects of rist4721 on the inflammatory response in healthy male subjects using a blister model

Conditions: Inflammatory Response

Summary: a randomised, single-blind, placebo-controlled, crossover study to investigate the effects of rist4721, a novel cxcr2 inhibitor, on the inflammatory response in healthy male subjects using a standardized blister model


Eligibility criteria:
inclusion criteria: * subject is male, with fitzpatrick skin types 1 to 3 * subject is aged between 18 to 55 years, inclusive * subject has a body mass index (bmi) of 18 to 32 kg/m2, inclusive * healthy as determined by a responsible physician, based on medical evaluation * must be willing to use birth control as indicated exclusion criteria: * subject is known to have immune deficiency or is immunocompromised * subject has had a recent acute infection or chronic infection * subject has a known or suspected allergy or contraindications to cantharidin (blister induction method), rist4721 or any component of the study drug * clinically relevant history of abnormal physical or mental health (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder)
oral bedtime melatonin in critically ill patients

Conditions: Septic Shock; Stroke Hemorrhagic; Strokes Thrombotic; Cardiac Arrest

Summary: oxidative stress is one of the main mechanisms causing harm in severe infection with septic shock, ischemia-reperfusion injury in resuscitated cardiac arrest and ischemic and hemorrhagic stroke. melatonin is a potent scavenger of the mediators of oxidative stress, oxygen and nitrogen-reactive species, which directly injure cell structures like walls and dna and thus cause organ dysfunction. in a previous study we have observed that high-dose oral bedtime melatonin (obm) is associated with improved organ function in severe covid-19 patients

this is a double-blind randomized, adaptive trial in the 4 indications mentioned above giving 100 mg of obm or placebo. interim analyses with pre-specified stopping rules will be performed in each sub-study for specific outcome variables collected at scheduled timelines. comparative organ dysfunction score (sequential organ failure evaluation-sofa) will be done at baseline, 7, 14, and 30 days and mortality evaluated at 30 and 90 days. for the 3 study groups enrolling stroke and resuscitated cardiac arrest patients, the modified rankin score and the cvc (glasgow) at 30 and 90 days will be compared.

Eligibility criteria:
inclusion criteria: * icu stay \>5 days exclusion criteria: * ominous prognosis